Regulatory Compliance Officer

3 days ago

Reading, Reading, United Kingdom Healthxchange Full time
Job Title: Regulatory Compliance Officer

We are looking for a highly skilled Regulatory Compliance Officer to join our team at Healthxchange. The successful candidate will have a strong background in regulatory compliance and be able to support the Responsible Person in maintaining compliance with Good Distribution Practise (GDP) guidelines.

The salary for this role is estimated to be around £55,000 - £65,000 per annum, depending on experience, based on London location.

About the Role:

The Regulatory Compliance Officer will be responsible for supporting the implementation and maintenance of Healthxchange's commitment towards Quality, GDP, GMP, GxP Pharmacy, and Regulatory standards. This includes providing daily support towards Healthxchange's operations licences at all sites, assisting the RP in implementing and maintaining Good Distribution Practise (GDP) standards across all Healthxchange operations, and acting as the Responsible Person in the RPs absence.

Key Responsibilities:

  • Support the implementation & maintenance of Healthxchange's commitment towards Quality towards GDP GMP GxP Pharmacy (oversight with support ex SI Pharmacist) & Regulatory standards
  • Provide daily support towards Healthxchange's operations licences at all sites; namely WDA(h) & MS licenses
  • Assist the RP in implementing and maintaining Good Distribution Practise (GDP) standards across all Healthxchange operations
  • Act as the Responsible Person in the RPs absence ensuring that all GDP related activities continue uninterrupted
  • Oversight and maintenance of our QA Management System (QMS) including document control change control validation management (systems and plant (PPM)) deviation management CAPA (Corrective and Preventative Action) programs complaint management and standard operating procedure (SOP) management and oversight
  • Document and report any deviations or issues identified during daily tasks
  • Assist in the development and maintenance of procedures protocols and departmental documentation
  • Support customer and vendor approval process with Head of Quality
  • Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations
  • Provide guidance and support to crossfunctional internal teams on QA related topics
  • Drive continuous improvement initiatives to enhance QA systems processes & performance
  • Maintain and support GDP/GMP training to internal colleagues to ensure staff are consistently aligned with industry body regulations and expectations
  • Assist the Head of Quality with the management and broadcast of QA KPIs to measure the efficacy of Quality within Healthxchange including trends and areas for improvement
  • Ensure timely resolution of QA related issues and deviations to minimize risk to customers patients and Healthxchange supply chain of products
  • Collaborate with external industry bodies to ensure compliance at Healthxchange is appropriate to current legislation
  • Support the Head of Quality in communications with external agencies and clients in all matters pertaining to QA/Regulatory including audit management at Healthxchange
  • Mentor and develop QA and Regulatory actions across all colleagues at Healthxchange

Requirements:

  • Bachelors degree in related field (Quality Assurance life sciences etc)
  • Minimum of 5 years experience in a QA role preferably in a pharmaceutical medical device global supply chain industry
  • Strong knowledge of Quality Management Systems (QMS) and regulations (GDP GMP GxP)
  • Strong analytical problemsolving and decisionmaking skills
  • Effective communication and interpersonal skills
  • Excellent attention to detail with strong analytical skills
  • Ability to work independently and collaboratively across multiple crossfunctional department
  • Preferred knowledge of Lean Six Sigma principles and methodologies
  • Proficient in Microsoft Office Suite (Word Excel PowerPoint)
  • Flexible to commute across all Healthxchange facilities

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